About this trial
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
Patients who do not exhibit symptoms suggestive of CAD
No other clinical CCTA subsequent to MI/PCI but prior to screening
eGFR >45 mL/min per most recent measurement within 90 days
Disqualifiers
Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
On PCSK9i and/or inclisiran at baseline
Reduced left ventricular ejection fraction (LVEF) <35%, if known
Prior coronary artery bypass graft (CABG)
Trial design
Parallel
Treatments tested in this trial
Heartflow Analysis
DeviceREWRITE-CAD will provide AI-CPA results
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Secondary outcomes
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)
Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy
Time to intensification of LLT
% Undergoing lipid testing
Sponsors and contacts
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HeartFlow, Inc.
Lead sponsor
Avania
Collaborator
This trial is not recruiting at the moment. You can still explore other options: